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510(k) Data Aggregation
K Number
K201138Device Name
AMSure® Single Use Saline Topical Solution
Manufacturer
Amsino Medical Inc.
Date Cleared
2021-04-14
(351 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Amsino Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in moistening and lubricating absorbent wound dressings for cuts, bruises and minor burns prior to removal from the wound area
Device Description
The subject AMSure® Single Use Saline Topical Solution device is normal saline 0.9% w/v Sodium Chloride. It is used in moistening and lubricating absorbent wound dressings for cuts, bruises, and minor burns prior to removal from the wound area. They are intended to be used in clinical and should only be used by clinicians familiar with the treatment of possible complications.
The subject device of normal saline topical solution 0.9% w/v is a unit-dose low density polyethylene (LDPE) vial contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives. The subject device is using blow fill seal technology. The devices are offered in 15mL, 35mL, 50mL.
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